FDA Requires New Labeling
For Glaxo's Drug Lotronex

WASHINGTON -- The Food and Drug Administration is requiring new labeling for Lotronex, a medication for irritable-bowel syndrome that has been linked to serious health problems.

The FDA has told Glaxo Wellcome Inc., which makes Lotronex, to issue an agency-reviewed medication guide to be distributed with vials of the drug -- the first time the agency has mandated such information under a 1999 rule. The guide instructs patients who become constipated or experience worsening abdominal pain while taking Lotronex to stop...